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Behavioural Therapy With Checklist for Overactive Bladder

Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03662893
Enrollment
120
Registered
2018-09-10
Start date
2015-01-01
Completion date
2018-04-15
Last updated
2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

overactive bladder, behavioural therapy, adherence, drug persistence

Brief summary

The aim of this study is to investigate the efficiency of this newly-established checklist for overactive bladder (OAB) and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.

Detailed description

Overactive bladder (OAB) can worsen quality of life but it is not life-threatening condition. Although OAB medications effectively decrease disturbing symptoms of OAB, there are a lot of adverse side effects such as dry mouth, cognitive changes, constipation, urinary retention, blurred vision and dyspepsia. Therefore, guidelines have firstly recommended behavioural therapy which are noninvasive and not linked with adverse side effects. These behavioural recommendations include an advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes to improve lower urinary tract symptoms of OAB. Educational leaflets, verbal or audio-visual instructions and trainings for behavioural therapy have been recommended for patients with OAB, however, to date these beneficial instructions have not been documented as a written checklist. Therefore, they were collected and developed as a written checklist to instruct the patients. The aim of this study was to investigate the efficiency of this newly-established checklist for OAB and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.

Interventions

BEHAVIORALbehavioural therapy with written checklist form to complete

Behavioural therapy for overactive bladder such as advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes

DRUGAntimuscarinic drugs used in overactive bladder

Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)

BEHAVIORALbehavioural therapy with written guideline

behavioural therapy with written guideline,which are the same as those in the checklist

Sponsors

Ministry of Health, Turkey
CollaboratorOTHER_GOV
Ankara Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Analysis of treatment response was performed by a single independent urologist blinded to the study groups.

Intervention model description

Group I were instructed to apply only written guideline forms of behavioural therapy which were the same as those in the checklist, Group II were instructed to apply behavioural therapy with a written checklist for patients to fully complete and Group III received medical treatment plus behavioural therapy without checklist. Group IV received medical treatment with a written checklist to fully complete

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Patients with * \>8 micturitions, * \>1 nocturia, * \>6 urgency or * \>3 urgency urinary incontinence episodes per 24 h according to 3-day bladder diary.

Exclusion criteria

* active urinary tract infection, * a maximum flow rate of 15 ml. per second or less at least 2 uroflow studies, * residual volume of 100 cc or more, * any medications for OAB, benign prostatic obstruction, * polyuria (\>3 l per 24 hour), * endocrinological disease such as diabetes mellitus or diabetes insipidus which can cause polyuria, * neurological or psychological disease disease, * prostate or bladder cancer, renal disease, hypertension, genitourinary or congenital abnormality, * history of transobturator or transvaginal tape or pelvic organ prolapse surgery * pelvic radiation or surgery

Design outcomes

Primary

MeasureTime frameDescription
Urinary frequency6 months\>8 micturitions per day
Urgency6 months\>6 urgency episodes per day

Secondary

MeasureTime frameDescription
Treatment Benefit Scale6 monthsTreatment Benefit Scale is consisted of four category including a score of 1 (greatly improved) or 2 (improved) is considered ''yes,'' and a score of 3 (not changed)or 4 (worsened) was considered ''no''
Urgency urinary incontinence6 months\>3 urgency urinary incontinence episodes per day
Nocturia6 months\>1 micturition at night

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026